The following data is part of a premarket notification filed by Freedom Designs, Inc. with the FDA for Spectrum Libre Wheelchair.
| Device ID | K993640 |
| 510k Number | K993640 |
| Device Name: | SPECTRUM LIBRE WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065 |
| Contact | Ginny S Maloco |
| Correspondent | Ginny S Maloco FREEDOM DESIGNS, INC. 2241 MADERA RD. Simi Valley, CA 93065 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-28 |
| Decision Date | 1999-11-16 |